Serious Complications with Surgical Mesh for
Gynecologic Surgery

FDA Patient Safety News: Show
#83, February 2009

The FDA is alerting healthcare professionals about rare but serious
complications associated with the surgical mesh used to treat pelvic
organ
prolapse and stress urinary incontinence. The mesh is usually placed
transvaginally using minimally invasive techniques.

Over the past three
years, FDA has received over a thousand reports of complications. The
most
frequent included erosion of the mesh through the vaginal epithelium,
infection,
pain, urinary problems, and recurrence of the prolapse or the
incontinence.
There were also reports of bowel, bladder, and blood vessel perforation
during
insertion. In some cases, vaginal scarring and mesh erosion led to a
significant
decrease in quality of life due to discomfort and pain, including
dyspareunia.

Treatment of the complications included IV therapy, blood transfusions,
drainage of hematomas or abscesses, and additional surgical procedures,
in some
cases to remove the mesh.

• Obtain
specialized training for each mesh placement technique, and be aware of
its
risks.

• Be vigilant for potential adverse events from the mesh,
especially erosion and infection, and also from the tools used in
transvaginal
placement, especially bowel, bladder and blood vessel perforations.

•
Inform patients about the potential for serious complications and their
effect
on quality of life, including scarring and pain during sexual
intercourse.
Patients should also be informed that implantation of surgical mesh is
permanent, and that some complications associated with the mesh may
require
additional surgery that may or may not correct the problem.

• Provide
patients with a written copy of the patient labeling from the surgical
mesh
manufacturer, if it is available.